Effect of intravenous acetaminophen in prevention of patent dactus arteriosus in preterm infants

Clinical trial of the effect of intravenous acetaminophen in patent ductus arteriosus prophylaxis of preterm infants with gestational age less than 32 weeks

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20111011007763N2

Enrollment

Registered

2018-03-03

Start date

2017-03-20

Completion date

Unknown

Last updated

2018-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Persistent ductus arteriosus. Patent ductus arteriosus

Interventions

Intervention 1: In the intervention group, an intravenous acetaminophen made by Iran Exir Company at a dose of 10 mg/kg is injected each 12 hours. Intervention 2: In the control group, for two days, i

Eligibility

Sex/Gender

All

Age

No minimum to 3 Days

Inclusion criteria

Inclusion criteria: Preterm infants with gestational age <32 weeks

Exclusion criteria

Exclusion criteria: Lethal anomalies Congenital heart diseases Existing patent ductus arteriosus

Design outcomes

Primary

Measure	Time frame
Opening of patent ductus arteriosus. Timepoint: 1 to 3 days after birth. Method of measurement: Echocardiography.	—

Secondary

Measure	Time frame
Intraventricular hemorrhage. Timepoint: 1 to 3 days after birth. Method of measurement: Brain sonography.;Gastrointestinal bleeding. Timepoint: 1 week. Method of measurement: Clinical examination.;Necrotizing enterocolitis. Timepoint: 1 week. Method of measurement: Clinical examination and stool exam.;Oliguria. Timepoint: 1 week. Method of measurement: Measurement of urine volume.;Pulmonary hemorrhage. Timepoint: 1 week. Method of measurement: Clinical examination.	—

Measure

Time frame

Intraventricular hemorrhage. Timepoint: 1 to 3 days after birth. Method of measurement: Brain sonography.;Gastrointestinal bleeding. Timepoint: 1 week. Method of measurement: Clinical examination.;Necrotizing enterocolitis. Timepoint: 1 week. Method of measurement: Clinical examination and stool exam.;Oliguria. Timepoint: 1 week. Method of measurement: Measurement of urine volume.;Pulmonary hemorrhage. Timepoint: 1 week. Method of measurement: Clinical examination.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNasim Meh

Mazandaran University of Medical Sciences

nasimmeh62@yahoo.com+98 11 3334 2334

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026